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Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV.
Trial Status: active
The Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women
Living with HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study is
evaluating immediate or delayed single-dose nonavalent HPV vaccination among women living
with HIV who received prior HPV vaccination.
Inclusion Criteria
Age 16 years and above on the day of signing the ICF
Living with HIV with confirmed test results or clinic records
History of receiving HPV vaccine
Self-reported sexually active in the last six months
Lives within the study area and willing to provide updated locator information over the course of the study
Does not have an autoimmune, degenerative, or genetic disease
Does not have known advanced HIV (as per stage IV WHO clinical staging criteria for HIV)
No other Investigator-determined factor would limit participation in the trial
Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study
The participant has a cervix
Exclusion Criteria
Anyone with cervical abnormality on examination
Anyone with an allergy to vaccine components or yeast
Additional locations may be listed on ClinicalTrials.gov for NCT06436274.
Locations matching your search criteria
The HOPE II Study is an individual-level, randomized trial of immediate or delayed
vaccination with a single-dose of the nonavalent HPV vaccine. The primary outcome is
single-dose HPV 16/18/31/33/45/52/58 vaccine efficacy (VE). The study will provide
evidence on the efficacy of single-dose HPV 16/18/31/33/45/52/58 vaccination among women
living with HIV.
Participants will be randomized 1:1 into two different Groups.
- Group 1: Will receive nonavalent HPV vaccine at Day 0 and meningococcal vaccine at
Month 18
- Group 2: Will receive the meningococcal vaccine at Day 0 and nonavalent HPV at Month
18
The meningococcal vaccine was chosen as the control vaccination because meningococcal
vaccination has no activity against HPV infection. Further, the meningococcal vaccine has
the potential to be of benefit in a meningitis outbreak context and could be beneficial
for young persons in a congregate setting such as tertiary institutions.
